Although industry 4.0 has so far been the most advanced of all industrial revolutions, it is in no way the last frontier. Industry 5.0 is already on the horizon. Below you will see how it will impact clinical research.

The fourth industrial revolution often called industry 4.0, introduced a series of innovative technologies into the world of production. The Internet of Things (IoT), robots, automation, sensors, advanced analysis and artificial intelligence have revolutionized production on an industrial scale and their impact is visible globally.

What makes the Industrial Revolution 4.0 different from the 5.0 revolution?

Industrial revolutions are stimulated both by the increase in the level of technological sophistication and by sociological trends. Industry 4.0 has been widely defined by the emergence of digitization and connectivity between different applications so that they can perform predefined activities independently. Industry 5.0 will be more of a change in the way humans will interact with these new technologies.

Technology will not replace human beings

Rather than replacing human labor, we will see the development of the so-called Super Smart Society, governed by the intelligent cooperation between humans and machines. In particular, the protagonists of Industry 5.0 will be Cobots and Intelligent Software applications (Bots). Cobots, unlike the robots currently used in production cycles, are collaborative robots. They are programmed to interact with humans in shared workplaces.

The Industrial Revolution 5.0 will be able to meet the growing demand for “customization” of mass products. The aim of industry 5.0 is, therefore, to use the capabilities of machines (obviously superior to ours) to maintain high production volumes but with superior quality, and through the guidance of the human mind, will be able to provide services and / or products to meet individual requirements.

Clinical research 5.0

In recent years, clinical research on drugs has undergone a profound and radical transformation thanks to the introduction of multiple digital technologies that have impacted on all the processes through which a clinical study is conducted, from feasibility to patient recruitment, drug management, and real-time metrics and data analysis.

Each clinical trial, while sharing common and universal processes, is, in any case, a unique entity, different from the others, which requires specific and targeted management by experienced operators who know how to make the best use of the support offered by the digital ecosystem.

The man-machine binomial

The 5.0 clinical trial puts professionalism and human experience back at the center, creating the “Human & Digital” duo. The study management team receives real-time data from a variety of different sources, such as monitors, investigators, and patients, and can use advanced analysis for ongoing insight and decision making throughout the study.

Using dashboards to view patient, center, and monitors’ performance data, the study manager controls any study metric and prioritizes the right actions at the right time.

Clinical trial 5.0 also allows the study promoter to override the traditional model of supervising CRO’s activity by conducting independent evaluations and establishing a proactive two-way discussion with CRO instead of reacting to what has been reported.

The clinical trial 5.0 according to Exom Group

Exom Group’s ‘Clinical Trial 5.0’ program is designed to make life easier for study participants by supporting them with innovative technologies and the expertise of its employees.

In particular, the benefits offered by a 5.0 clinical trial are manifold:

  • ensures the achievement of higher quality standards and prevents any risk that could potentially damage the study data and results.
  • allows to speed up, optimize, and accelerate the process of implementing any protocol changes in the case of an “adaptive” study.
  • drastically reduces the time to access “interim analysis” data.
  • eliminates the activity of data entry by the researcher and subsequent verification by the monitor, through the direct capture of data into the eCRF, from the electronic medical records of the center (eSource).
  • puts the patient at the center of the clinical trial through the remote collection and real-time analysis of his parameters, measured in real-life conditions.
  • drives any human operational action through the support of advanced analytics and predictive models
  • provides the promoter with real-time access to the progress of the study with a complete, detailed, and updated view of every management aspect.

Exom Group’s digital ecosystem 5.0

Genius Suite, the digital ecosystem of Exom Group’s clinical trial 5.0 is validated and complies with both European (GDPR) and North American (HIPPA) privacy and international regulatory rules and offers the functionality to support human operators in the supervision and management of all processes.

The aforementioned digital ecosystem integrates a series of the most innovative tools used to efficiently plan, manage, and evaluate the progress of the clinical trial.

In what way? Through the Single-Sign-On (SSO) technology, it is possible to access the following modules of the Genius Suite platform:


The concept of man and software working in tandem in clinical research 5.0  involves the combination of two components:

  • Use of integrated technologies for repetitive, precision and human resource-intensive activities of low professionalism
  • Involvement of qualified and experienced professionals for the personalized management of the study, to make the appropriate decisions and to think radically outside the box.

Unlike the industrial revolution 5.0, clinical research 5.0 is not a future prospect, but is already a concrete reality that not only does not limit the potential of stakeholders, be they investigators, patients, monitors, study managers, data managers or promoters, but, on the contrary, enhances their role and performance.


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